MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K W/O OLC & DIASAFE WITH H.P.

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

A user facility reported saline bag back filled during the first setup of the day after recirculation had been running for an unknown time.There was no patient involvement.On site technician replaced loading pressure regulator and flow relief valve.Following the replacement the issue could not be duplicated.Since the repair the system is ready for use but has been set aside as a spare device.

Manufacturer Narrative

Investigation findings to date indicate the reported malfunction occurred during recirculation and prime (machine set-up) and not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been no adverse events associated with this reported issue.This report is being investigated by the manufacturer via a capa.The investigation is pending; a supplemental mdr will be filed at the completion of the investigation.

• Brand Name: 2008K W/O OLC & DIASAFE WITH H.P.
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3826228
• MDR Text Key: 18794372
• Report Number: 2937457-2014-00271
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN SALINE (DISCARDED - NOT USED)